MedDataX Logo

Alcohol 20% for Separation of Pterygium and Comparison of Different Wound Closure Methods

NCT ID: NCT00704977

Last Updated: 2008-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Purpose of this study is to evaluate efficiency and safety of Alcohol 20% for peeling pterygium and to compare 3 different methods of operative wound closure: Bare sclera, Sliding flap, Amniotic membrane + biological glue

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Pterygium is a fibrovascular tissue growing on conjunctiva and cornea. The disturbance/morbidity caused by pterygium is diverse, ranging from mild esthetic disturbance and till recurrent inflammations and significant decrease of visual acuity. Rate of pterygium is between 20%-49% of general population, while increase in these numbers is observed in the population of equatorial regions. Pterygium usually appears at age of 22-49 years. While the rate of pterygium appearance increases with the age, the recurrence rate after surgical removal is higher in younger patients. Treatment of pterygium is surgical. The main challenges during surgery are peeling of pterygium and prevention of recurrence. During the last two decades several methods were developed and became widely accepted for pterygium surgery. The emphasis in modifying pterygium surgery is done on initial phase of surgery - techniques of pterygium separation and the final phase - the wound closure methods, additionally adjuncts (such as Mitomycine C) became widely used. These modifications are considered to improve the surgical outcomes and decrease the rate of complications and recurrence rate. Currently popular techniques of pterygium separation include Blunt dissection + keratectomy (blunt separation of the tissue + dissection of superficial layers of cornea); Avulsion technique (Avulsion of the pterygium head by creating tension on the cap edge+ further optional blunt dissection); Air assisted dissection (injection of air into the side of pterygium cap to create good separation plane).

Alcohol 20% is widely used in surface refractive surgery, where it helps to peel easily the epithelium of the cornea. Several reports show a positive role of alcohol in treatment of recurrent corneal erosions resistant to other treatments. At microscopic level - the ethanol splits basement membrane at the level between lamina lucida and lamina densa, additionally ethanol destroys the hemidesmosome junctions between epithelial cells. No consensus exists on ethanol influence on keratocyte viability and function: some studies show delayed wound healing and significant keratocyte damage, while other works show no significant alteration in keratocyte number while using alcohol.

At the phase of pterygium separation our purpose is to check the safety and efficiency of alcohol 20% for peeling of pterygium from ocular surface.

Various closure techniques exist, 3 of the widespread techniques are: Bare sclera (with adjunct such as mitomycine C) - the wound is left as it is, without closure. Sliding conjunctival flap- conjunctiva from adjacent region is dissected, moved to the wound area and sutured. Amniotic membrane transplantation, using biological glue to adhere the membrane. Amniotic membrane does not carry HLA antigens - so that no HLA compatibility tests are needed. Amniotic membrane underwent screening of infectious diseases and was cryopreserved. Amniotic membrane is applied with its mesenchimal part towards sclera and basement membrane side upwards. Adhesion of amniotic membrane is achieved by biological glue (containing thrombin and calcium as main ingredients)

We intend to compare each of these methods of wound closure in conjunction with using alcohol 20 % for pterygium separation.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pterygium

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Pterygium surgery using alcohol 20% + wound closure by bare sclera technique

Group Type ACTIVE_COMPARATOR

pterygium surgery using alcohol 20% for tissue separation and bare sclera as wound closure technique

Intervention Type PROCEDURE

The eye operated is disinfected and covered according routine protocol.

Tightly applying well above the pterygium area. Instilling alcohol 20% into the well and holding for 40-60 seconds. Absorbing alcohol by applicator and abundant irrigation with BSS.

Pterygium separation starting 2 mm centrally from the edges of the tissue. Excising the pterygium tissue at the base. Applying mytomycin C for 2.5 min+ abundant irrigation with BSS.

Wound closure by by technique described in each arm.

Bandage with chloramphenicol ointment or with Maxitrol ointment (Dexamethasone/Neomycin/Polymyxin B Eye Ointment.

Postoperative treatment include :antibiotic and steroid eyedrop treatment at least 2 weeks.

Follow up at 1 week, 1 month, 3 months, 6 months, 1 year. If additional follow upvisits are needed - they will be accomplished according the patients condition and needs.

2

Alcohol 20% for pterygium separation + wound closure by sliding flap technique.

The main steps of surgery are described below.Wound closure technique is as follows.

Disection of conjunctiva adjascent to the wound, bringing the dissected conjunctiva to the wound area and suturing by vicril 6/0 sutures

Group Type ACTIVE_COMPARATOR

pterygium surgery using alcohol 20% for tissue separation and bare sclera as wound closure technique

Intervention Type PROCEDURE

The eye operated is disinfected and covered according routine protocol.

Tightly applying well above the pterygium area. Instilling alcohol 20% into the well and holding for 40-60 seconds. Absorbing alcohol by applicator and abundant irrigation with BSS.

Pterygium separation starting 2 mm centrally from the edges of the tissue. Excising the pterygium tissue at the base. Applying mytomycin C for 2.5 min+ abundant irrigation with BSS.

Wound closure by by technique described in each arm.

Bandage with chloramphenicol ointment or with Maxitrol ointment (Dexamethasone/Neomycin/Polymyxin B Eye Ointment.

Postoperative treatment include :antibiotic and steroid eyedrop treatment at least 2 weeks.

Follow up at 1 week, 1 month, 3 months, 6 months, 1 year. If additional follow upvisits are needed - they will be accomplished according the patients condition and needs.

3

Alcohol 20 % for pterygium separation + using amniotic membrane and biological glue for wound closure.

The steps of surgery are as described below, wound closure technique is as follows.

Amniotic membrane is applied with its mesenchimal side to conjunctiva and glued by biological glue (main ingradients: calcium and thrombin)

Group Type ACTIVE_COMPARATOR

pterygium surgery using alcohol 20% for tissue separation and bare sclera as wound closure technique

Intervention Type PROCEDURE

The eye operated is disinfected and covered according routine protocol.

Tightly applying well above the pterygium area. Instilling alcohol 20% into the well and holding for 40-60 seconds. Absorbing alcohol by applicator and abundant irrigation with BSS.

Pterygium separation starting 2 mm centrally from the edges of the tissue. Excising the pterygium tissue at the base. Applying mytomycin C for 2.5 min+ abundant irrigation with BSS.

Wound closure by by technique described in each arm.

Bandage with chloramphenicol ointment or with Maxitrol ointment (Dexamethasone/Neomycin/Polymyxin B Eye Ointment.

Postoperative treatment include :antibiotic and steroid eyedrop treatment at least 2 weeks.

Follow up at 1 week, 1 month, 3 months, 6 months, 1 year. If additional follow upvisits are needed - they will be accomplished according the patients condition and needs.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pterygium surgery using alcohol 20% for tissue separation and bare sclera as wound closure technique

The eye operated is disinfected and covered according routine protocol.

Tightly applying well above the pterygium area. Instilling alcohol 20% into the well and holding for 40-60 seconds. Absorbing alcohol by applicator and abundant irrigation with BSS.

Pterygium separation starting 2 mm centrally from the edges of the tissue. Excising the pterygium tissue at the base. Applying mytomycin C for 2.5 min+ abundant irrigation with BSS.

Wound closure by by technique described in each arm.

Bandage with chloramphenicol ointment or with Maxitrol ointment (Dexamethasone/Neomycin/Polymyxin B Eye Ointment.

Postoperative treatment include :antibiotic and steroid eyedrop treatment at least 2 weeks.

Follow up at 1 week, 1 month, 3 months, 6 months, 1 year. If additional follow upvisits are needed - they will be accomplished according the patients condition and needs.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age- above 18 years old.
* Primary pterygium.
* Eligibility to sign the informed consent.

Exclusion Criteria

* Unwillingness to participate in study.
* Hypersensitivity to materials/ medications used during the surgery.
* Pregnancy.
* Cases when the eye which should be operated is the only fuctional eye.
* Age less than 18 years old.
* Recurrent pterygium.
* Chronic eye diseases, especially ocular surface disorders such as: OCP, severe blepharitis, severe keratoconjunctivitis,atopic eye disorders.

Patients which are not eligible to sign independently the informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Soroka University Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Soroka university Medical center, chief of ophthalmology department

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tova Lifshitz, MD

Role: PRINCIPAL_INVESTIGATOR

Professor, Chief of ophthalmology department and clinics, SorokaUniversity Medical Center, Israel

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Soroka University Medical Center, Ophthalmology department and outpatient clinics

Beersheba, , Israel

Site Status RECRUITING

Soroka University Medical Center

Beersheba, , Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Tova Lifshitz, MD

Role: CONTACT

Phone: 972-8-6400288

Email: [email protected]

Anry Pitchkhadze, MD

Role: CONTACT

Phone: 972-8-6400556

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Tova Lifshitz, MD

Role: primary

Anry Pitchkhadze, MD

Role: backup

Tova Lifshitz, MD

Role: primary

Anry Pitchkhadze, MD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

sor471508ctil

Identifier Type: -

Identifier Source: org_study_id